The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

Compositions and methods for regulating the blood coagulation pathway are disclosed. More particularly, the present disclosure relates to thrombin-thrombomodulin fusion proteins, vectors, host cells and methods for preparing the thrombin-thrombomodulin fusion proteins. The present disclosure further relates to methods for measuring protein C in plasma and kits for measuring protein C in plasma.

The invention provides a method of defining the likelihood of a subject having bladder cancer, comprising the steps of: (A) assessing the subject's likelihood of having bladder cancer by: i. identifying at least one sub-population group appropriate to the subject; ii. determining the level of one or more biomarkers selected according to the sub-population group in a sample obtained from the subject; iii. inputting each of the biomarker values into an algorithm to produce an output value; and iv. correlating the output value with the likelihood of the subject having bladder cancer, wherein the sub-population group is selected according to smoking habits, gender, presence/absence of stone disease, history of benign prostate enlargement (BPE) or prescription of anti-hypertensive, anti-platelet and/or anti-ulcer medication, and (B) determining the subject's stratified risk level of serious disease by: v. determining the level of one or more biomarkers specific for one or more risk classifiers defined using Random Forest Classifiers (RFC), logistic regression or another appropriate systems biology or statistical approach in a sample obtained from the subject, vi. inputting each of the biomarker values into an algorithm or algorithms to produce an output value; and vii. correlating the output value with a stratified risk level of underlying serious disease, wherein the likelihood of having bladder cancer is combined with the stratified risk level of having serious disease, wherein the risk of having bladder cancer and/or serious disease is categorized as: high-risk bladder cancer requiring immediate cystoscopy; low-risk bladder cancer requiring urgent cystoscopy; high-risk control requiring close evaluation and further investigation; or low-risk control requiring primary care monitoring.

The present invention relates generally to the identification and isolation of human otic progenitor cells. More specifically, the present invention relates to a method of using cell markers to identify and isolate human otic progenitor cells from a mixed population of cells, methods of enrichment and production of human otic progenitor cells, and associated kits for use in identification and/or isolation of human otic progenitor cells, wherein the cell markers are selected from SSEA1 (CD15), disialoganglioside GD3, TRA-2-49 (liver/bone/kidney alkaline phosphatase), SSEA4, ganglioside GD2 and CD141.

The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

A method of diagnosing long-COVID in a subject, the method comprising: (a) measuring the level of one or more biomarkers in a test sample obtained from the subject, and (b) comparing the level of the one or more biomarkers in the test sample with a healthy control and/or an acute COVID-19 reference level value of said one or more biomarkers, wherein an increase in the level of the one or more biomarkers in the test sample relative to the healthy control and/or acute COVID-19 reference level value of said one or more biomarkers is indicative of long-COVID diagnosis, and wherein the one or more biomarkers are selected from Table 5. In one embodiment, the one or more biomarkers include ANG-1, P-Sel and MMP-1. A method of treating long-COVID comprising administering to a subject one or more of the biomarkers are selected from Table 5.

This disclosure provides methods and devices for determining a quantitative estimate of thrombomodulin levels in a mammalian subject suspected of internal hemorrhaging. The method includes applying a blood sample from the subject to a handheld assay device capable of providing optical quantitation of the amount of thrombomodulin in the sample, measuring, by means of said assay device, an analyte signal value correlated to a concentration of the thrombomodulin in the blood sample and comparing the analyte signal value to a minimum threshold, wherein an analyte signal value less than the minimum threshold indicates that the subject is not internally hemorrhaging, and an analyte signal value above the minimum threshold indicates the subject is internally hemorrhaging. The methods and devices are adapted to rapidly assess internal hemorrhaging and hemorrhagic shock in a patient outside of hospital settings.